MR Guided High Intensity Focused Ultrasound for Lumbar Back Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02291978|
Recruitment Status : Recruiting
First Posted : November 17, 2014
Last Update Posted : August 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lumbar Facet Joint Pain||Device: ExAblate 2100||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility Study to Evaluate the Safety and Initial Effectiveness of MR Guided High Intensity Focused Ultrasound (MRgHIFU) in the Treatment of Facetogenic Lumbar Back Pain|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2020|
Experimental: ExAblate 2100 Treatment
The ExAblate 2100 system will be used in the MRgHIFU treatment of lower back pain arising from facet joint arthritis.
Device: ExAblate 2100
The InSightec ExAblate 2100 MRgHIFU system is a non-invasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue and bone.
- Device Related Complications as a Measure of Safety [ Time Frame: 24 months ]Safety will be determined by evaluating for the incidence and severity of any device related complication from the treatment day visit through 24 months after treatment.
- Pain Relief on the Visual Analog Scale [ Time Frame: 24 months ]Effectiveness will be determined by the level of pain relief, as measured by the NRS, and decrease in analgesic/opiate use.
- Quality of Life Improvement [ Time Frame: 24 months ]Effectiveness will be determined by improved quality of life, as measured by the Oswestry Disability Index.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291978
|Contact: Kara Richardsonfirstname.lastname@example.org|
|United States, California|
|Stanford, California, United States, 94305|
|Contact: Kara Richardson 650-561-5237 email@example.com|
|Principal Investigator: Pejman Ghanouni, MD, PhD|
|Principal Investigator:||Pejman Ghanouni, MD, PhD||Stanford University|